SWitching Acenocoumarol to Phenprocoumon for improved anticoagulation control during point-of-care INR monitoring (SWAP-trial)

- candidate number

21957

- NTR Number

NTR5169

- ISRCTN

ISRCTN no longer applicable

- Date ISRCTN created

- date ISRCTN requested

- Date Registered NTR

16-apr-2015

- Secondary IDs

2015-001757-33 EUDRACT

- Public Title

SWitching Acenocoumarol to Phenprocoumon for improved anticoagulation control during point-of-care INR monitoring (SWAP-trial)

- Scientific Title

SWitching Acenocoumarol to Phenprocoumon for improved anticoagulation control during point-of-care INR monitoring (SWAP-trial)

- ACRONYM

SWAP

- hypothesis

Prior studies have shown reagent dependent differences in sensitivity to circulating clotting factor VII (FVII). This reagent dependent sensitivity to FVII can explain the INR differences between laboratory methods and point-of care devices found in earlier studies. Since FVII fluctuation and consequent INR variation is significantly lower in patients treated with the long-acting phenprocoumon compared to the short-acting acenocoumarol, switching patients from acenocoumarol to phenprocoumon may improve anticoagulant control during point-of-care INR monitoring

1.Provision of informed consent prior to any study specific procedures.
2.Patients with an indication for anticoagulant treatment with vitamin K antagonists who are treated with acenocoumarol.
3. Patients aged 18 years or above.
4. The patient has a target INR of 3.0 (therapeutic range 2.0-3.5) or 3.5 (therapeutic range 2.5-4.0)
5. The patient has an expected treatment duration of 6 months or longer from the moment of study entry
6. The patient is expected to have at least 3 months of treatment with VKA’s before study entry

- Exclusion criteria

1. Patients who self-monitor their INR.
2. Patients who are treated with VKA other than acenocoumarol.
3. The patients’ life expectancy is less than 6 months.
4. Pregnant women, women who are breast feeding, and women of childbearing potential who are not intending to practice an adequate method of contraception during their participation in the study.
5. Patients with a scheduled chirurgical procedure during the study period

- mec approval received

no

- multicenter trial

no

- randomised

yes

- masking/blinding

None

- control

Active

- group

Parallel

- Type

Single arm

- Studytype

intervention

- planned startdate

1-sep-2015

- planned closingdate

1-sep-2018

- Target number of participants

880

- Interventions

We will perform a single-center, prospective, open-label, randomized clinical trial, to determine if switching from acenocoumarol to phenprocoumon can improve time in therapeutic range during POC INR monitoring by a specialized anticoagulation clinic.
After informed consent, patients will be allocated to either switch to phenprocoumon or to continue their treatment with acenocoumarol. After a transition period of 1 month, patients will be followed up for 6 months and TTR and secondary end points will be assesse

- Primary outcome

Percentage of time in therapeutic range at study end

- Secondary outcome

1. INR testing frequency
2. Percentage of measurements in therapeutic range
3. Percentage of INR followed by a significant dose adjustments, defined as any dose adjustment of 10% or more
4. Percentage INR variation
5. Difference in treatment satisfaction score (0-100), based on the visual analogue scale at study end